ModifiedmhnPolicy CP.PHAR.613

Fecal Microbiota, Live-jslm (Rebyota) coverage

This policy governs medical necessity criteria, dosing, and coverage stance for Rebyota (fecal microbiota, live-jslm) for prevention of recurrent Clostridioides difficile infection in individuals 18 years and older for Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyFecal Microbiota, Live-jslm (Rebyota) coverage

Policy CodePolicy CP.PHAR.613

Change TypeHCPCS addedprior-antibiotic example removedreferences updated

Effective DateMar 1, 2023

Next Review Date

Key ActionSubmit prior authorization showing all initial approval criteria are met for a single 150 mL rectal dose of Rebyota and reference HCPCS J1440 on claims.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J1440 for Fecal microbiota, live - jslm, 1 ml.

Removed metronidazole as an example of prior antibiotic therapy.

Annual reviews noted no significant clinical changes; references updated.

single dosemaximum administered per approval

3 monthsinitial approval duration

≥18minimum age for coverage

J1440HCPCS code referenced

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Coverage Criteria for Rebyota (fecal microbiota, live-jslm)

Initial Approval — Prevention of CDI

Covered when ALL of the following are met:

Initial approval criteria: 1) Diagnosis of CDI confirmed by documentation of positive C. difficile test; 2) Age >= 18 years; 3) Member has recurrent CDI evidenced by either (a) at least 2 episodes of CDI recurrence after a primary episode (total 3 episodes) OR (b) at least 2 episodes of severe CDI resulting in hospitalization within the last year; 4) Member has received at least 10 consecutive days of antibiotic therapy for the current CDI (examples: vancomycin, fidaxomicin); 5) Current CDI is controlled (<3 unformed/loose stools/day for 2 consecutive days, e.g., Bristol Stool Scale types 6-7); 6) Member has not previously received Rebyota, Vowst, or prior fecal microbiota transplant; 7) Dose does not exceed a single dose of 150 mL.see individual nodes

Approval duration: 3 months (1 dose only)

Re-authorization / Repeat Course

Re-authorization not permitted:

No re-authorization: Re-authorization is not permitted as the efficacy of repeat courses of Rebyota has not been sufficiently established; clinical trial experience is limited (open-label retreatment response was low) and the FDA label indicates a single dose without addressing repeat courses.n/a

Approval duration: Not applicable

Coverage for Rebyota is not authorized for non‑FDA‑approved indications unless the provider supplies sufficient clinical documentation demonstrating efficacy and safety in accordance with the plan's off‑label use policies. See the referenced off‑label policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) or the member’s evidence of coverage documents for allowable exceptions.

Where this clinical policy conflicts with state Medicaid program rules, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage requirements and any differences from this policy prior to submitting authorization requests or claims.

Repeat courses or re‑authorization of Rebyota are not permitted. The evidence supporting efficacy of repeat treatment is insufficient: in the pivotal trial only a small subset received a second open‑label course and response rates were limited, and the FDA label specifies a single dose without guidance on repeat dosing. Requests for additional courses will therefore be denied.

Coding, Dose, and Age Requirements

HCPCS Codes referencedHCPCS

J1440

Fecal microbiota, live - jslm, 1 ml

HCPCS CodesHCPCSCovered

J1440

Fecal microbiota, live - jslm, 1 ml

inv-08: Dose — single dose of 150 mL rectally

DoseSingle dose — 150 mL administered rectally

Maximum per approvalOne 150 mL dose (approval duration: 3 months)

Administration routeRectal instillation

inv-09: Antibiotic duration for current CDI — at least 10 consecutive days

Required antibiotic durationAt least 10 consecutive days of antibiotic therapy for the current CDI (e.g., vancomycin, fidaxomicin)

Examples of antibioticsVancomycin, fidaxomicin

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rebyota (HCPCS J1440). Providers must request prior authorization before administration and ensure documentation supports that the member meets all approval criteria.

HCPCS: J1440 — Fecal microbiota, live - jslm, 1 mL (use for claims and prior auth submission)
Rebyota single dose: 150 mL rectal dose (one-time administration)

Documentation Required

Required Documentation and Re-Authorization Risk

Providers must submit documentation (e.g., office chart notes, hospital records, laboratory results, antibiotic treatment history) demonstrating the member meets all approval criteria. Failure to provide required documentation may result in denial of the prior authorization or failure of re-authorization.

Acceptable documentation: positive Clostridioides difficile test result, stool frequency/control documentation, antibiotic administration records, hospitalization records for severe CDI, prior therapy attempts

Background on Rebyota and Indication

Rebyota (Fecal Microbiota, Live‑jslm) is a fecal microbiota suspension derived from qualified human donors and is indicated to prevent recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI. Clinical society guidance supports fecal microbiota transplantation for patients with multiple recurrences, and recurrence risk increases with successive CDI episodes.

Definitions and Clinical Terms

inv-22: CDI incident vs recurrent — definitions per IDSA

Incident CDINew primary symptom onset with positive C. difficile test (per IDSA) — considered an incident case

Recurrent CDISymptom onset with positive C. difficile assay following a previous positive result; policy requires ≥2 recurrences after primary episode (total 3 episodes) or ≥2 severe CDI hospitalizations in the prior year

Policy useRecurrent CDI definition is required to meet initial approval criteria for Rebyota

inv-23: Controlled CDI / Bristol Stool Scale — stool frequency/consistency thresholds used in policy

Controlled current CDIDefined as <3 unformed/loose stools per day for 2 consecutive days

Bristol Stool Scale referenceTypes 6-7 indicate diarrheal stool and are used to identify unformed/loose stools

Policy Revision History and Changes

2023-05-23material_operational_change

HCPCS code J1440 (Fecal microbiota, live - jslm, 1 ml) was added and billing systems should map the product to J1440; providers should reference J1440 on prior authorization and claims.

2023-05-23billing_instruction

Operational instruction recorded that billing systems should map the product to HCPCS J1440 for Rebyota.

2022-12-14policy_inception

Policy Summary

Payermhn

PolicyFecal Microbiota, Live-jslm (Rebyota) coverage

Policy CodePolicy CP.PHAR.613

Change TypeHCPCS addedprior-antibiotic example removedreferences updated

Effective DateMar 1, 2023

Next Review Date

Key ActionSubmit prior authorization showing all initial approval criteria are met for a single 150 mL rectal dose of Rebyota and reference HCPCS J1440 on claims.

SourceLink

On This Page

Documented completion of ≥10 days required for initial approval

inv-10: Age — >= 18 years

Minimum age for coverage>= 18 years

FDA indication age detailIndicated for prevention of recurrent CDI in individuals 18 years of age and older following antibiotic treatment

Not indicated for pediatric usePolicy and FDA indication restrict to adults ≥18

inv-11: Timing after antibiotics — administer 24 to 72 hours after last antibiotic dose

Timing after antibioticsAdminister 24 to 72 hours after the last dose of antibiotics for CDI

ContextSpecified for prevention dosing regimen following completion of antibiotic therapy

DocumentationTiming should be documented in administration records for prior authorization/claims

inv-12: N/A (placeholder key/value)

N/ANo additional threshold specified

Coding thresholdNo value provided in policy thresholds section

NotesPlaceholder — no applicable threshold

Re-authorization: Not permitted — do not submit requests for repeat Rebyota courses

Step Therapy

Prior Antibiotic Trials Required

Prior appropriate antibiotic treatments for the CDI must be documented before Rebyota is approved. Examples include fidaxomicin or vancomycin (standard or tapered/pulsed regimens) as described in clinical guidance.

Examples of acceptable prior antibiotic therapy: fidaxomicin 200 mg PO BID for 10 days (or 5 days then QOD for 20 days); vancomycin 125 mg PO QID for 10 days or tapered/pulsed regimens
Documentation should show at least 10 consecutive days of antibiotic therapy for the current CDI episode as required in initial criteria

Billing Rule

Coding and Documentation Guidance

Use up-to-date professional coding guidance when submitting claims. Submit prior authorization and claims using HCPCS code J1440 to avoid coding-related denials. Include clinical documentation with the prior authorization request and retain records supporting medical necessity for audit.

Code to use on claims and PA: J1440 — Fecal microbiota, live - jslm, 1 mL
Attach supporting documentation to the PA: positive CDI test, antibiotic history, stool control status, dosing (single 150 mL dose), and any hospitalization records

Denial Risk

Coding-Related Denial Risk

Failure to submit claims using HCPCS code J1440 or failure to include required supporting documentation may lead to coding-related denials or denial of the prior authorization request.

Verify payer-specific billing instructions and submit claims with J1440 and appropriate units (150 mL = 150 mL; J1440 is reported per mL)
Keep documentation available for audit and appeals if a denial occurs

Assessment requirementDocument stool frequency/consistency in clinical notes to show current CDI is controlled

inv-24: Rebyota (Fecal microbiota, live-jslm) — product definition

Product name (term)Rebyota (Fecal microbiota, live-jslm)

HCPCS codingMapped to HCPCS J1440 (Fecal microbiota, live - jslm, 1 ml) per coding implications

Indication summaryIndicated to prevent recurrence of CDI in adults ≥18 years following antibiotic treatment for recurrent CDI

Policy created (Policy created, Date = 12.14.22) establishing coverage criteria for Rebyota.

2023-02-23governance_approval

Policy received P&T approval (P&T Approval Date = 02.23).

2023-10-06informational_update

1Q 2024 annual review noted no significant clinical changes and references were reviewed and updated.

2024-10-17informational_update

1Q 2025 annual review noted no significant clinical changes and references were reviewed and updated.

2025-10-23informational_updateLatest

1Q 2026 annual review noted no significant clinical changes and references were reviewed and updated.